At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 2 enrolled
Drug / intervention
Vemurafenibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Study of Neoadjuvant Vemurafenib in Melanoma Patients With Untreated Brain Metastases, Whose Tumors Harbor B-raf Mutations
In Brief
A Phase 2 clinical trial evaluating Vemurafenib for Melanoma. Completed, enrolled 2 participants across 1 site.
Detailed Summary
The purpose of this trial is to study the activity of vemurafenib in untreated melanoma brain metastases harboring B-Raf proto-oncogene, serine/threonine kinase (BRAF) mutations that are not amenable to stereotactic radiosurgery based on size, number of lesions or location, to measure cerebrospinal fluid (CSF) levels of vemurafenib as an indicator of central nervous system penetrance and to measure levels of vemurafenib in normal brain tissue and brain metastases in those in whom surgical management is feasible.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesUnited States
CollaboratorsGenentech, Inc.
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 2013
Enrollment StartApr 2013
Primary CompletionJun 2014
TodayJul 2026
First PostedJan 31, 2013
Enrollment StartApr 1, 2013
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.4 years ago
Interventions
Vemurafenibdrug
Single arm trial